Clinical Research Regulatory Coordinator | Oncology Therapeutics

The Pennsylvania State University; Hershey (PA); Sur place; USD 54 000 - 86 000; Plein temps

Avantages offerts par ce poste

75% tuition discount

Résumé du poste

The Pennsylvania State University is seeking a Clinical Research Regulatory Coordinator in Hershey, PA to manage regulatory activities for oncology trials conducted by the Experimental Therapeutics team. You will ensure compliance with FDA regulations, ICH-GCP guidelines, and institutional policies while coordinating start-up, maintenance, and closeout activities.

The role requires a Bachelor's degree with 3+ years of regulatory experience in clinical research, familiarity with IND studies, and

Qualifications

• Bachelor's Degree and 3+ years of regulatory experience in clinical research.
• Experience with IND studies and ICH-GCP guidelines.
• Familiarity with FDA regulations and IRB submissions.
• Ability to manage multiple trials and deadlines.

Responsabilités

• Coordinate regulatory start-up and activation for oncology trials across sponsors and investigators.
• Prepare and submit IRB applications, continuing reviews, amendments, and consent revisions.
• Maintain ISFs and regulatory files; monitor approvals and compliance deadlines.
• Serve as regulatory lead for assigned trials; liaise with investigators, sponsors, CROs, and regulatory offices.
• Support study closeout, sponsor monitoring, and regulatory inspections.

Connaissances

Regulatory affairs

Oncology experience

IRB submissions

Regulatory documentation

Formation

Bachelor's Degree

Outils

eRegulatory systems

Description du poste

Clinical Research Regulatory Coordinator | Oncology Therapeutics### Clinical Research Regulatory Coordinator | Oncology TherapeuticsApply: College of Medicine: Full time: Posted Today: REQ\\_0000083757# **APPLICATION INSTRUCTIONS:*** ## CURRENT PENN STATE EMPLOYEE (faculty, staff, technical service, or student), please login to Workday to complete the internal application process. Please do not apply here, apply internally through Workday.* ## CURRENT PENN STATE STUDENT (not employed previously at the university) and seeking employment with Penn State, please login to Workday to complete the student application process. Please do not apply here, apply internally through Workday.* ## If you are NOT a current employee or student, please click “Apply” and complete the application process for external applicants.### **Approval of remote and hybrid work is not guaranteed regardless of work location. For additional information on remote work at Penn State, see Notice to Out of State Applicants.**This position is funded for 1 year(s); continuation past 1 year(s) will be based on university need, performance, and/or availability of funding.### **POSITION SPECIFICS**The Penn State College of Medicine, in Hershey, Pa is seeking a Clinical Research Regulatory Coordinator. This position is responsible for the regulatory management of Oncology clinical trials conducted by the Experimental Therapeutics (Extract) Team at Penn State College of Medicine. This position independently manages regulatory activities across an assigned portfolio of oncology clinical trials, supporting study start-up, activation, ongoing maintenance, and closeout. Working closely with Principal Investigators, clinical research staff, sponsors, contract research organizations (CROs), and institutional regulatory offices, the coordinator ensures regulatory compliance with institutional policies, FDA regulations, and Good Clinical Practice (GCP) guidelines. The ideal candidate will have experience in clinical research regulatory affairs, preferably within oncology therapeutics, strong organizational skills, and the ability to independently manage multiple studies and competing deadlines. **Essential Duties and Responsibilities****1. Regulatory Study Start-Up and Maintenance*** Coordinate regulatory start-up and activation activities for industry-sponsored, investigator-initiated, cooperative group, and federally sponsored oncology trials.* Prepare and submit initial IRB applications, continuing reviews, protocol amendments, informed consent revisions, personnel changes, and other required regulatory submissions.* Collect, review, and maintain essential regulatory documents, including protocols, investigator brochures, CVs, licenses, training records, and financial disclosures.* Independently manage regulatory requirements and submission timelines for an assigned portfolio of clinical trials.* Maintain accurate, complete, and current regulatory files and Investigator Site Files (ISFs).* Monitor regulatory approvals, expiration dates, training requirements, and compliance deadlines. **2. Oncology-Specific Regulatory Compliance*** Provide regulatory support for Phase I, II, and III oncology therapeutic clinical trials involving investigational agents and novel cancer treatments.* Coordinate regulatory documentation and requirements associated with IND studies, investigational products, safety updates, and protocol amendments.* Ensure compliance with applicable FDA regulations, ICH-GCP guidelines, and institutional research policies.* Identify and address regulatory deficiencies and ensure study documentation remains current and compliant. **3. Quality Assurance and Study Closeout*** Maintain regulatory files in an audit- and inspection-ready state.* Coordinate preparation for sponsor monitoring visits, internal audits, and regulatory inspections.* Perform quality checks to ensure regulatory documentation is accurate, complete, and compliant.* Coordinate final regulatory submissions, IRB study closure, and long-term document archiving **4. Communication and Collaboration*** Serve as a primary regulatory contact for assigned oncology clinical trials.* Collaborate with investigators, clinical research coordinators, research nurses, sponsors, CROs, and institutional regulatory personnel.* Communicate regulatory requirements, timelines, and outstanding documentation needs to research team members.* Contribute to regulatory process improvements and support research staff with study-specific regulatory requirements. **Preferred Qualifications*** Previous experience in oncology clinical research, preferably supporting oncology therapeutic clinical trials.* Experience with Phase I, II, and/or III oncology clinical trials.* Experience with regulatory submissions for industry-sponsored, investigator-initiated, and cooperative group oncology studies.* Familiarity with FDA regulations, IND studies, and ICH-GCP guidelines.* Experience with IRB submissions and electronic regulatory document management systems. **MINIMUM EDUCATION, WORK EXPERIENCE & REQUIRED CERTIFICATIONS**If filled as Clinical Research Coordinator - Advanced Professional, this position requires:Bachelor's Degree3+ years of relevant experience; or an equivalent combination of education and experience acceptedRequired Certifications:NoneIf filled as Clinical Research Coordinator - Intermediate Professional, this position requires:Bachelor's Degree1+ years of relevant experience; or an equivalent combination of education and experience acceptedRequired Certifications:None### **BACKGROUND CHECKS/CLEARANCES**This position requires the following clearances in addition to applicable background checks: PA State Police Criminal Background Check, PA Child Abuse History Clearance Form, and Federal (FBI) Fingerprint Criminal Background Check.### Penn State does not sponsor or take over sponsorship of a staff employment Visa. Applicants must be authorized to work in the U.S. **SALARY & BENEFITS**The salary range for this position, including all possible grades, is $54,060.00 - $86,400.00. Salary Structure - Information on Penn State's salary structure Penn State provides a competitive benefits package for full-time employees designed to support both personal and professional well-being. In addition to comprehensive medical, dental, and vision coverage, employees enjoy robust retirement plans and substantial paid time off which includes holidays, vacation and sick time. One of the standout benefits is the generous 75% tuition discount, available to employees as well as eligible spouses and children. For more detailed information, please visit our Benefits Page.